Setting of import tolerances for cyantraniliprole in rice and coffee beans

Transcription

1 REASED PII APPRVED: 17 March 2016 PUBLISHED: 8 April 2016 doi: /j.efsa Setting of import tolerances for cyantraniliprole in rice and coffee beans Abstract European Food Safety Authority (EFSA) In accordance with Article 6 of Regulation (EC) o 396/2005, the evaluating Member State (EMS), France, received from Dupont de emours and Syngenta Crop Protection AG an application to set import tolerances for the active substance cyantraniliprole in rice and coffee beans in order to accommodate the authorized uses in Brazil and Colombia on coffee and in China and Vietnam on rice. Import tolerance proposals of 0.05 mg/kg on coffee beans and of 0.01* mg/kg on rice were derived from the submitted residue trials. However, since the highest tolerance value established on coffee beans in the exporting countries is set at 0.03 mg/kg, EFSA proposes to maintain in the EU legislation the MRL value of 0.03 mg/kg reported under Regulation (EU) o 2015/845. o change is necessary for rice, as the MRL value is currently set at the default limit of quantification of 0.01 mg/kg. European Food Safety Authority, 2016 Keywords: cyantraniliprole, rice, coffee, MRL application, consumer risk assessment Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2016;14(4):4447

2 Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the modification of the maximum residue levels for cyantraniliprole in rice and coffee. EFSA Journal 2016;14(4):4447, 14 pp. doi: /j.efsa ISS: European Food Safety Authority, 2016 Reproduction is authorised provided the source is acknowledged. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 2 EFSA Journal 2016;14(4):4447

3 Summary In accordance with Article 6 of Regulation (EC) o 396/2005, the evaluating Member State (EMS) France, received an application from Dupont de emours and Syngenta Crop Protection AG to set import tolerances for the active substance cyantraniliprole in rice and coffee in order to accommodate the authorized uses in Brazil and Colombia on coffee and in China and Vietnam on rice. France drafted an evaluation report in accordance with Article 8 of Regulation (EC) o 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 9 ovember EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Regulation (EC) 1107/2009, the conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole, the JMPR Evaluation report as well as the conclusion from a previous EFSA opinion on cyantraniliprole. The toxicological profile of cyantraniliprole was assessed in the framework of the peer review under Regulation (EC) o 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.01 mg/kg bw per day. o acute reference dose (ARfD) was deemed necessary. The metabolism of cyantraniliprole in primary crops was investigated in the fruit, leafy, cereal/grass and pulses/oilseeds crop groups following foliar and soil applications. From these studies the peer review established the residue definition as cyantraniliprole for monitoring and risk assessment. For the uses on the crops under consideration, EFSA concludes that the metabolism of cyantraniliprole in primary crops has been sufficiently addressed and that the residue definitions derived are applicable. Import tolerance proposals of 0.05 mg/kg on coffee beans and of 0.01* mg/kg on rice were derived from the submitted residue trials. However, since the highest tolerance value established on coffee beans in the exporting countries is set at 0.03 mg/kg, EFSA proposes to maintain in the EU legislation the MRL value of 0.03 mg/kg reported under Regulation (EU) o 2015/845. o change is necessary for rice, as the MRL value is currently set at the default limit of quantification of 0.01 mg/kg. Adequate analytical methods are available to monitor the residues of cyantraniliprole in the commodities under consideration at the validated LQ of 0.01 mg/kg. Processing studies on coffee and rice were not provided and are not requested as the total theoretical maximum daily intake (TMDI) for each crop was calculated to be less than 10 % of the ADI. The assessments of the residues in rotational crops and in animal commodities are of no relevance for the assessment of import tolerances. Since no changes in the MRL values currently set for coffee beans and rice in the EU legislation are proposed, an update of the consumer risk assessment is not requested. The assessment conducted in the previous EFSA reasoned opinion where the highest chronic intake was estimated to be 43% of the ADI, remains valid. Based on the available information, no changes to the MRLs currently into force at EU level are required as summarised in the table below: Code (a) Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/Justification Enforcement residue definition: Cyantraniliprole Rice (b) 0.01* o change The submitted trials conducted in China result in an import tolerance proposal of 0.01* mg/kg Coffee beans 0.03 o change An import tolerance proposal of 0.05 mg/kg was derived from the submitted trials. However, as the highest tolerance established in the exporting countries refers to the CXL of 0.03 mg/kg, EFSA proposes to maintain the MRL at 0.03 mg/kg (a): Commodity code number according to Annex I of Regulation (EC) o 396/2005 (b): Default MRL value of 0.01 mg/kg (LQ) according to Article 18(1)(b) of Regulation (EC) o 396/2005 (*): indicates that the MRL is set at the limit of analytical quantification (LQ) 3 EFSA Journal 2016;14(4):4447

4 Table of contents Abstract... 1 Summary... 3 Background... 5 The active substance and its use pattern... 5 Assessment Method of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues ature and magnitude of residues in plant Primary crops Rotational crops ature and magnitude of residues in livestock Consumer risk assessment Conclusions and recommendations References Abbreviations Appendix A Good Agricultural Practice (GAPs) Appendix B Used compound codes EFSA Journal 2016;14(4):4447

5 Background Regulation (EC) o 396/ establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at European Union (EU) level. Article 6 of the Regulation lays down that any party having a legitimate interest or requesting an authorisation for the use of a plant protection product in accordance with Council Directive 91/414/EEC, 2 repealed by Regulation (EC) o 1107/2009, 3 shall submit to a Member State, when appropriate, an application to set a MRL in accordance with the provisions of Article 7 of the Regulation. France, hereafter referred to as the evaluating Member State (EMS), received an application from the company DuPont de emours 4 and Syngenta Crop Protection AG 5 to set import tolerances for cyantraniliprole in rice and coffee, based on the uses of the active substance in Vietnam and China (rice) and in Columbia and Brazil (coffee). This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission and to EFSA on 9 ovember The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Cyantraniliprole - Modification MRLs in rice and coffee beans (green) France proposed to raise the existing MRL from 0.03 mg/kg to 0.05 mg/kg in coffee beans and to maintain the LQ of 0.01* mg/kg in rice. EFSA proceeded with the assessment of the application and the evaluation report as required by Article 10 of the Regulation. In accordance with Article 10 of Regulation (EC) o 396/2005, EFSA shall, based on the evaluation report provided by the EMS, provide a reasoned opinion on the risks to the consumer associated with the application. In accordance with Article 11 of the Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within three months (which may be extended to six months if more detailed evaluations need to be carried out) from the date of receipt of the application. If EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. The active substance and its use pattern Cyantraniliprole is the IS common name for 3-bromo-1-(3-chloro-2-pyridyl)-4 -cyano-2 -methyl-6 - (methylcarbamoyl)pyrazole-5-carboxanilide (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix B. Cyantraniliprole has been approved for the uses as insecticide. Cyantraniliprole is a new active substance currently not yet approved under Regulation (EC) o 1107/2009, for which the European Commission has established the completeness of the application dossier and the date of admissibility of the application was recognised as being 10 August The representative uses evaluated in the peer review were foliar applications on various crops. The draft assessment report (DAR) has been peer reviewed by EFSA (EFSA, 2014). In accordance with Article 11(2) of the Regulation (EC) o 1107/2009, the DAR included an MRL application to set MRLs on a 1 Regulation (EC) o 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. J L 70, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. J L 230, , p Regulation (EC) o 1107/2009 of the European Parliament and of the Council of 21 ctober 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. J L 309, , p Du Pont de emours GmbH, Hugenottenallee , 63263, eu-isenburg, Germany 5 Syngenta Crop Protection AG, Schwarzwaldallee 215, 4002, Basel, Switzerland 5 EFSA Journal 2016;14(4):4447

6 wide range of crops which have not yet been implemented in the European legislation. The peer review has been finalised, but a final decision concerning the approval of cyantraniliprole under Regulation (EC) o 1107/2009 is pending. The EU MRLs for cyantraniliprole are established in Annex IIIA of Regulation (EC) o 396/2005. Table 1: verview of the MRL changes since the entry into force of Regulation (EC) o 396/2005 Procedure (a) Considered by Regulation Remarks Peer review (EFSA, 2014) ot yet implemented The DAR included proposal to set MRLs, in accordance with Article 11(2) of the Regulation (EC) o 1107/2009 Art. 10 (EFSA, 2015) ot yet implemented Cherries, strawberries, carrots, other root and tuber vegetables, Brussels sprouts, beans/peas (without pods), globe artichokes, herbal infusions, cucumbers (import tolerance) Implementation of CXL (EU) o 2015/845 FA, 2014 (a): Art. 10: Assessment of MRL application according to Article 6 to 10 of Regulation (EC) o 396/2005 Codex Alimentarius has established maximum residue limits (CXL) for a wide range of commodities, including coffee beans for which a CXL of 0.03 mg/kg is set. There is no CXL set for rice. According to the clarification received from the applicant, the residue tolerance for coffee beans is set at 0.01 mg/kg in Brazil and at the CXL level of 0.03 mg/kg in Colombia. A temporary MRL 0.2 mg/kg was established on rice in China, but a tolerance is not established in Vietnam. The details of the authorised GAPs for cyantraniliprole on coffee in Brazil and Colombia and on rice in China and Vietnam are given in Appendix A. Assessment EFSA bases its assessment on the evaluation report submitted by the EMS (France, 2013), the DAR prepared under Regulation (EC) o 1107/2009 (United Kingdom, 2013), the conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole (EFSA, 2014), the JMPR Evaluation report (FA, 2014) as well as the conclusion from a previous EFSA opinion on cyantraniliprole (EFSA, 2015). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) o 546/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a g, 2000, 2010a, b, 2011; ECD, 2011). 1. Method of analysis 1.1. Methods for enforcement of residues in food of plant origin The enforcement residue definition for cyantraniliprole residues in plant commodities has been agreed during the peer review as cyantraniliprole (EFSA, 2014). Analytical methods for the determination of cyantraniliprole residues in plant commodities were assessed during the peer review under Regulation (EC) o 1107/2009 (EFSA, 2014). The multiresidue method DFG S19 using LC-MS/MS quantification and its ILV were concluded to be fully validated for the determination of cyantraniliprole and its metabolite I-J9Z38 in high water (apple, peach, tomato, lettuce, cucumber), high acid (orange, lemon, lime), high oil (almond, rape seed) and 6 Commission Regulation (EU) o 546/2011 of 10 June 2011 implementing Regulation (EC) o 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. J L 155, , p EFSA Journal 2016;14(4):4447

7 high starch (wheat grain, potato) content matrices and in processed commodities (tomato paste and sun dried tomato) at the LQ of 0.01 mg/kg for each analyte. As rice and coffee beans belong to the group of high starch and high oil content commodities, EFSA concludes that a sufficiently validated analytical method is available to control cyantraniliprole residues in the crops under consideration Methods for enforcement of residues in food of animal origin Analytical methods for the determination of cyantraniliprole residues in food of animal origin were not assessed, since MRL proposals are not derived for animal commodities in the framework of the current application. 2. Mammalian toxicology The toxicological profile of the active substance cyantraniliprole was assessed in the framework of the peer review under Regulation (EC) o 1107/2009 (EFSA, 2014). The data were sufficient to derive toxicological reference values compiled in Table 2. Table 2: verview of the toxicological reference values Cyantraniliprole Source Year Value Study Safety factor ADI EFSA mg/kg bw per day 1 year dog 100 ARfD EFSA 2014 ot necessary The toxicity of plant and livestock metabolite I-J9Z38 is considered to be covered by the toxicological reference values derived for parent cyantraniliprole (EFSA, 2014). 3. Residues 3.1. ature and magnitude of residues in plant Primary crops ature of residues The metabolism of cyantraniliprole in primary crops was evaluated in the framework of the peer review under Regulation (EC) o 1107/2009 in the fruit, leafy, cereals and pulses/oilseeds crop groups after foliar and soil applications. An overview of the available metabolism studies is presented in Table 3. Table 3: Summary of available metabolism studies in plants Crop group Crops Application Fruit Tomato Foliar (3x 150 g/ha, BBCH 14-61) 125 DAT 3 Soil drench (3x 150 g/ha, BBCH 19-61) Sampling (a) (DAT) (leaves, fruits) Leafy Lettuce Foliar (3x 150 g/ha, BBCH 14-18) 0, 7, 14, 32 DAT 3 Comments Foliar applications: 14 C-cyano and 14 C- pyrazole cyantraniliprole in a 1:1 mixture formulation. Cereals / Grass Soil drench (3x 150 g/ha, BBCH 18-19) 7, 14, 32 DAT 3 Rice Foliar (3x 150 g/ha, BBCH 13/14) 140 DAT 3 (straw, grain) Soil granule (1x 300 g/ha, BBCH 13) 175 DAT (straw, grain) Soil applications: Separate studies with each label. Pulses / ilseeds Cotton Foliar (3x 150 g/ha, BBCH 16-19) 124 DAT 3 (leaves, bolls) (a): DATx, days after treatment x Soil drench (3x 150 g/ha, BBCH 19) 125 DAT 3 (leaves, bolls) 7 EFSA Journal 2016;14(4):4447

8 Based on the metabolism studies the residue definition was proposed as cyantraniliprole for monitoring and risk assessment in the conclusion of the peer review (EFSA, 2014). The current residue definition set in Regulation (EC) o 396/2005 is the same as derived in the peer review. For the uses on the crops under consideration, EFSA concludes the residue definition for enforcement and risk assessment agreed during the peer review is applicable Magnitude of residues a. Coffee beans (GAP Brazil: 2x 175 g/ha, PHI 28 days) (GAP Colombia: 2x 175 g/ha, PHI 7 days) The applicant submitted eight residue trials on coffee performed in Brazil in Trials were not GAP compliant since conducted with two soil treatments at 200 g/ha before the foliar applications. The soil applications were performed 60 and 30 days prior to the first foliar application. However, in two locations, a parallel plot was treated according to the GAP with a total of two foliar applications and residue levels in coffee beans of <0.01 to 0.02 mg/kg, being similar to the levels observed in the plots where additionally soil treatments were applied (<0.01 to 0.03 mg/kg). Therefore EFSA concludes that the contribution of soil applications to the final residue levels in coffee beans at harvest can be considered negligible and that these trials are valid for the setting of an MRL according to the proposed GAPs which are limited to foliar applications. Based on these data, MRL proposals of 0.03 and 0.05 mg/kg were derived considering the residue levels observed at 7 and 28 day PHI (Colombian and Brazilian GAPs respectively). However, since the MRL established in Brazil is limited to 0.01 mg/kg and to the CXL of 0.03 mg/kg in Colombia, EFSA does not recommend the setting of an import tolerance of 0.05 mg/kg and proposes to maintain the MRL at the value of 0.03 mg/kg, as already set under Regulation (EU) o 2015/ b. Rice (GAP Vietnam, China: 2x 100 g/ha, PHI 14 days) The applicant submitted six residue trials on rice, performed in China during growing seasons 2010 and 2011 according to the supported GAP. Cyantraniliprole residues were all below the LQ (0.01 mg/kg). Rice is a major crop, but as no residues above the LQ were observed in the available trials, the number of trials is considered sufficient to propose an MRL at the LQ of 0.01 mg/kg. This proposal is similar to the default MRL value of 0.01 mg/kg currently set for rice according to Article 18(1)(b) of Regulation (EC) o 396/2005. The results of the residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposals are summarised in Table 4. The stability of residues under storage conditions was assessed during the peer review (EFSA, 2014). Residues of cyantraniliprole were found to be stable at - 20 C for up to 24 months in high water, high acid and dry/starch matrices, and up to 18 months in high oil and dry/protein matrices. As the trial samples were stored up to 15 months under conditions for which integrity of the samples was demonstrated, it is concluded that the residue data are valid with regard to storage stability. According to the EMS, the analytical methods used to analyse the residue trial samples have been sufficiently validated and were proven to be fit for purpose (France, 2013). EFSA concludes that there is no need to modify the existing MRLs for cyantraniliprole in coffee beans and rice and proposes to maintain the following MRL values in the EU legislation: - Coffee beans: 0.03 mg/kg an import tolerance of 0.05 mg/kg was derived from the submitted dataset, but the implementation of this value is not recommended as the MRL currently into force in the exporting country is 0.03 mg/kg. - Rice: 0.01* mg/kg the submitted dataset results in an MRL proposal of 0.01* mg/kg. 7 Commission Regulation (EU) 2015/845 of 27 May 2015 amending Annexes II and III to Regulation (EC) o 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, chlorantraniliprole, cyantraniliprole, dicamba, difenoconazole, fenpyroximate, fludioxonil, glufosinate-ammonium, imazapic, imazapyr, indoxacarb, isoxaflutole, mandipropamid, penthiopyrad, propiconazole, pyrimethanil, spirotetramat and trinexapac in or on certain products. J L 138, , p EFSA Journal 2016;14(4):4447

9 Table 4: verview of the available residues trials data Crop (supported GAP) Coffee (2x 175 g/ha, 7/28 d PHI) Rice (2x 100 g/ha, 14 d PHI) Country (a) Residue levels observed in the supervised residue trials (b) (mg/kg) Brazil 7 day PHI: 3 x <0.01; <0.01; 0.01; 0.02; 0.02; day PHI: 5x <0.01; <0.01; 0.01; 0.02 Recommendations/comments (c) Underlined values: GAP compliant trial (2 foliar applications) ther: 2 soil applications (200 g/ha) and 2 foliar applications 7 d PHI: MRL ECD =0.05/ d PHI: MRL ECD =0.03/0.03 MRL proposal (mg/kg) 0.05 or 0.03 HR (d) (mg/kg) China 6x < * (*): Indicates that the MRL is proposed at the limit of analytical quantification (LQ). (a): EU: utdoor trials conducted in northern Europe, SEU: utdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non-eu trials. (b): Individual residue levels considered for MRL calculation are reported in ascending order (2x <0.01, 0.01, 6x 0.02, 0.04, 0.08, 2x 0.10, 0.15, 0.17), (c): Any information/comment supporting the decision and ECD MRL calculation (unrounded/rounded values) (d): HR: Highest residue level according to the residue definition for risk assessment. (e): STMR: Median residue level according to residue definition for risk assessment STMR (e) (mg/kg) EFSA Journal 2016;14(4):4447

10 Effect of industrial processing and/or household preparation Standard hydrolysis studies simulating the effect on the nature of cyantraniliprole residues under processing conditions representative of pasteurisation, boiling and sterilisation were assessed in the peer review (EFSA, 2014). It was concluded that the active substance is hydrolytically stable under pasteurisation and sterilisation, but slightly degraded under boiling conditions to metabolites I-J9Z38 (12 to 14 % AR), I-5M09 and I-F6L99 (5 to 8 % AR), resulting from the cleavage of the parent compound. The residue definitions in processed commodities were therefore proposed as cyantraniliprole for enforcement and as the sum of cyantraniliprole and I-J9Z38 expressed as cyantraniliprole for risk assessment (EFSA, 2014). It is, however, highlighted that toxicological data are still requested for metabolites I-5M09 and I- F6L99 as in some processed commodities these metabolites accounted for up to 0.09 mg/kg (EFSA, 2014). Specific studies to assess the magnitude of cyantraniliprole residues during the processing of coffee beans and rice are not necessary as the total theoretical maximum daily intake (TMDI) for each of the crop amounts to less than 10 % of the ADI (European Commission, 1997d) Rotational crops The residues of cyantraniliprole in rotational crops are not of relevance for the assessment of import tolerances and therefore this point was not considered in this reasoned opinion ature and magnitude of residues in livestock Although rice straw is used as a livestock feed in EU, it is unlikely that straw will be imported to Europe for feed purposes and therefore the nature and magnitude of cyantraniliprole residues in livestock was not further investigated. 4. Consumer risk assessment Since no changes in the MRL values currently set for coffee beans and rice in Regulation (EU) o 2015/845 are proposed, the consumer risk assessment conducted in the previous EFSA reasoned opinion (EFSA, 2015), where the highest chronic intake was estimated to be 43% of the ADI, remains valid and an update of this assessment is not requested. Conclusions and recommendations Based on the available information, no changes to the MRLs currently into force at EU level are required, as summarised in the table below: Code (a) Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/Justification Enforcement residue definition: Cyantraniliprole Rice (b) 0.01* o change The submitted trials conducted in China result in an import tolerance proposal of 0.01* mg/kg Coffee beans 0.03 o change An import tolerance proposal of 0.05 mg/kg was derived from the submitted trials. However, as the highest tolerance established in the exporting countries refers to the CXL of 0.03 mg/kg, EFSA proposes to maintain the MRL at 0.03 mg/kg (a): Commodity code number according to Annex I of Regulation (EC) o 396/2005 (b): Default MRL value of 0.01 mg/kg (LQ) according to Article 18(1)(b) of Regulation (EC) o 396/2005 (*): indicates that the MRL is set at the limit of analytical quantification (LQ) 10 EFSA Journal 2016;14(4):4447

11 References EFSA (European Food Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. EFSA Journal 2007, 32r, doi: /j.efsa r EFSA (European Food Safety Authority), Conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole. EFSA Journal 2014;12(9):3814, 249 pp. doi: /j.efsa EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing MRLs for cyantraniliprole in various crops. EFSA Journal 2015;13(10):4263, 25 pp. doi: /j.efsa European Commission, Appendix G. Livestock Feeding Studies. 7031/VI/95-rev.4. European Commission, 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev.3. European Commission, 1997b. Appendix B. General recommendations for the design, preparation and realisation of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. European Commission, 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. European Commission, 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. European Commission, 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. European Commission, 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5. European Commission, 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. European Commission, Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414). SAC/3029/99- rev.4. European Commission, 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SAC 10634/2010 Rev. 0, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of March European Commission, 2010b. Residue analytical methods. For post-registration control. SAC/825/00-rev.8.1. European Commission, Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. FA (Food and Agriculture rganization of the United ations), Cyantraniliprole In: Pesticide residues in food Evaluations. Part I. Residues. FA Plant Production and Protection Paper 220. France, Evaluation report on the setting of MRL for cyantraniliprole in rice and coffee prepared by the evaluating Member State France under Article 8 of Regulation (EC) o 396/2005, 30 July ECD (rganisation for Economic Co-operation and Development), ECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March In: Pesticide Publications/Publications on Pesticide Residues. Available online: United Kingdom, Draft assessment report on the active substance cyantraniliprole prepared by the rapporteur Member State the United Kingdom in the framework of Regulation (EC) o. 1107/2009, May EFSA Journal 2016;14(4):4447

12 Abbreviations ADI AR ARfD BBCH bw CXL DAR DAT EMS FA GAP GCPF HPLC HR ILV IS IUPAC JMPR LQ MRL MS/MS MW D ECD PHI PRIMo RMS STMR TMDI WH acceptable daily intake applied radioactivity acute reference dose growth stages of mono- and dicotyledonous plants body weight Codex maximum residue limit (Codex MRL) draft assessment report days after treatment evaluating Member State Food and Agriculture rganization of the United ations good agricultural practice Global Crop Protection Federation (formerly International Group of ational Associations of Manufacturers of Agrochemical Products (GIFAP)) high performance liquid chromatography highest residue independent laboratory validation International rganization for Standardization International Union of Pure and Applied Chemistry Joint FA/WH Meeting on Pesticide Residues limit of quantification maximum residue level tandem mass spectrometry detector molecular weight oil dispersion rganisation for Economic Co-operation and Development pre-harvest interval (EFSA) Pesticide Residues Intake Model rapporteur Member State supervised trials median residue theoretical maximum daily intake World Health rganization 12 EFSA Journal 2016;14(4):4447

13 Appendix A Good Agricultural Practice (GAPs) Crop and/or situation (a) Coffee Rice MS or EU/SEU or Country Colombia Brazil Vietnam F G or I (b) F F F Pest or group of pests controlled (c) Hypothenemus hampei Hypothenemus hampei, Leucoptera coffeella ilaparvata lugens, Scripophaga incertulas, Cnaphalocrocis medinalis Formulation Application Application rate per treatment type (d-f) D D D China F D conc. a.s. (i) 100 g/l 100 g/l 100 g/l 100 g/l Method kind (f-h) Foliar Foliar Growth stage & season (j) days after flowering At early berry formation umber min-max (k) 1 per season (max 2 x per year) Interval minmax g/hl min-max Water L/ha min-max g/ha min-max PHI (days) (l) Foliar Foliar Remarks (m) GAP reported for the JMPR evaluation refers to a PHI of 28 days (FA, 2014) Remarks: (a) For crops, EU or other classifications, e.g. Codex, should be used; where relevant, the usage situation should be described (e.g. fumigation of a structure) (b) utdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil-born insects, foliar fungi, weeds (d) e.g. wettable powder (WP), water soluble granule (WG) (e) GCPF Codes - GIFAP Technical Monograph o 2, 1989 (f) all abbreviations must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants. type of equipment used must be indicated (i) (j) (k) (l) (m) g/kg or µg/l Growth stage at last treatment (Meier U, Growth Stages of mono- and dicotyledonous plants. BBCH Monograph, 2 nd Ed., Federal Biological Research Centre of Agriculture and Forestry, Braunschweig, Germany, 2001), including where relevant, information on season at time of application The minimum and maximum number of application possible under practical conditions of use must be provided PHI - minimum pre-harvest interval Remarks may include: Extent of use/economic importance/restrictions 13 EFSA Journal 2016;14(4):4447

14 Appendix B Used compound codes Code/Trivial name Chemical name Structural formula cyantraniliprole 3-bromo-1-(3-chloro-2-pyridyl)-4 -cyano-2 - methyl-6 -(methylcarbamoyl)pyrazole-5- carboxanilide H CH 3 H Br MW: CH 3 Cl I-J9Z38 2-[3-bromo-1-(3-chloropyridin-2-yl)-1H- pyrazol-5-yl]-3,8-dimethyl-4-oxo-3,4- dihydroquinazoline-6-carbonitrile CH 3 Cl Br CH3 I-MLA84 2-[3-bromo-1-(3-chloropyridin-2-yl)-1H- pyrazol-5-yl]-8-methyl-4-oxo-1,4- dihydroquinazoline-6-carbonitrile H Cl Br CH 3 I-7B69 3-bromo-1-(3-chloropyridin-2-yl)--[4- cyano-2-(hydroxymethyl)-6- (methylcarbamoyl)phenyl]-1h-pyrazole-5- carboxamide H H Cl H CH 3 Br I-MYX98 3-bromo-1-(3-chloropyridin-2-yl)--{4- cyano-2-[(hydroxymethyl)carbamoyl]-6- methylphenyl}-1h-pyrazole-5-carboxamide H H H CH 3 Br Cl I-5M09 6-chloro-4-methyl-11-oxo-11H-pyrido[2,1- b]quinazoline-2-carbonitrile Cl CH 3 I-F6L99 3-bromo--methyl-1H-pyrazole-5- carboxamide H CH 3 H Br 14 EFSA Journal 2016;14(4):4447